Validation of the Mexican-Spanish Version of the EORTC QLQ-OV28 Instrument for the Assessment of Quality of Life in Women with Ovarian Cancer

Abstract

Health-related quality of life (HRQL) is an important outcome measure in Oncology. To validate the Mexican-Spanish version of the QLQ-OV28 questionnaire to assess HRQL in women with ovarian cancer (OC). The QLQ-C30 and QLQ-OV28 instruments were applied to women with OC attending a cancer center in Mexico. The usual psychometric analyses were performed; the Spearman's method was used for correlation analysis, reliability analysis with the Cronbach's alpha, known-group comparisons with the Kruskal-Wallis test, responsiveness was tested employing repeated measures ANOVA, and the association of scale scores and overall survival (OS) were analyzed with the Kaplan-Meier method and Cox's model. Two hundred fifty-two women with OC were included in this cohort. The instruments were well accepted and compliance rates were high; patients responded both instruments in <30min. The QLQ-OV28 internal consistency tests demonstrated good convergent (Correlation coefficients [CC] 0.154‒0.694) and divergent validity (CC 0.003‒0.69). Cronbach's α coefficients of six of eight scales of the QLQ-OV28 instruments were >0.7 (range, 0.567‒0.857). Scales QLQ-OV28 instruments distinguished among clinically distinct groups of patients, particularly after basal serum albumin and basal Ca‒125 levels. The evaluation of responsiveness demonstrated that two scales of the QLQ-OV28 were sensitive to change over time during induction chemotherapy. Six scales of the QLQ-OV28 were associated with OS. The Mexican-Spanish version of the QLQ-OV28 questionnaire is reliable and valid for the assessment of HRQL in patients with OC and can be broadly used in clinical trials.